Add Blood Clot Warning To AstraZeneca Vaccine, Advises EU Regulator
The EU’s medicines regulator, European Medicines Agency, has advised that a warning be added to the Oxford-AstraZeneca product information.
The regulatory body said on Thursday that it could not rule out a link between the AstraZeneca coronavirus vaccine and a rare clotting disorder, despite insisting that the vaccine is safe.
The EMA had declared the vaccine “safe and effective” at a press briefing on Thursday, stating that it was not linked to an increased risk of blood clots.
“The committee has come to a clear scientific conclusion: this is a safe and effective vaccine,” European Medicines Agency chief, Emer Cooke, told a press conference after a probe by the body’s safety committee.
“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events [blood clots], Cooke added.
She said that the EMA recommended adding a warning to the vaccine’s product information.
This would draw attention to the “possible rare conditions” to help patients and healthcare professionals “stop and mitigate any possible side effects,” said Cooke.
There had been 469 reports of blood clotting among 20 million people who had been vaccinated in the European Economic Area (EU, Norway, Iceland and Liechtenstein) and Britain, the EMA said in a separate statement.
In all 191 were from the EEA, it said.
Comparing this figure to cases in the general population, it had found that there was no increase in the overall risk of blood clot, it said.
It found just 25 cases of the rare condition involving low levels of platelets. Almost all of these were in women under 55.
“However, in younger patients there remain some concerns, related in particular to these rare cases,” it added.
There was meanwhile “no evidence of a problem” linked to specific batches of the vaccine — one of the early lines of inquiry, the EMA said.
Nor was there any suspected connection with particular vaccine factories.